Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-02 @ 3:19 PM
Study NCT ID:
NCT07128251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)
Sponsor:
Anhui Provincial Hospital
Organization:
Study Overview
Official Title:
A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.
Detailed Description:
This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.
After signing the informed consent form (ICF) and passing screening, subjects will undergo the first TACE procedure. Conventional TACE (cTACE) will be performed using lipiodol as the embolic agent and epirubicin as the chemotherapeutic agent. Study drug administration will commence at least 2 weeks after the first TACE: Iparomlimab and Tuvonralimab Injection \[7.5 mg/kg, intravenous infusion, Day 1 (D1) of each cycle, every 21 days (Q3W)\] combined with Bevacizumab Injection \[15 mg/kg, intravenous infusion, D1, Q3W\]. Each treatment cycle is 21 days (Q3W). On-demand TACE therapy will be administered concurrently, with a maximum of 4 TACE sessions permitted. The interval between consecutive TACE sessions must be at least 4 weeks. Bevacizumab Injection must be withheld for at least 2 days prior to any TACE procedure. Study drug administration must resume at least 2 weeks after any TACE procedure. Subjects must have fully recovered from TACE prior to receiving study drugs. Investigators may delay dosing based on toxicity recovery, but study drugs should be administered as soon as feasible once requirements are met.
Treatment will continue until the investigator assesses no further clinical benefit for the subject, the subject experiences intolerable toxicity, withdraws consent, or meets other protocol-specified criteria for treatment discontinuation (whichever occurs first).
Safety Visits: After enrollment, safety assessments will be performed 2 weeks (14 ± 3 days) after each TACE procedure and on D1 of each study drug cycle prior to drug administration. Subjects will continue safety assessments and survival follow-up after treatment completion.
Safety Reporting Period: Starts from the first TACE treatment and ends 90 days after the last dose of Iparomlimab and Tuvonralimab Injection \[non-serious adverse events (AEs) unrelated to study drugs are collected only until 30 days after the last dose\], or 30 days after the last dose of Bevacizumab Injection, or 30 days after the last TACE procedure, whichever is later.
Survival Follow-up: After the safety visit period, survival status and subsequent anti-tumor therapies will be collected every 12 weeks (±7 days) via clinical or telephone follow-up until subject death, loss to follow-up, sponsor study termination, or other study completion criteria are met (whichever occurs first).
After signing the informed consent form (ICF) and passing screening, subjects will undergo the first TACE procedure. Conventional TACE (cTACE) will be performed using lipiodol as the embolic agent and epirubicin as the chemotherapeutic agent. Study drug administration will commence at least 2 weeks after the first TACE: Iparomlimab and Tuvonralimab Injection \[7.5 mg/kg, intravenous infusion, Day 1 (D1) of each cycle, every 21 days (Q3W)\] combined with Bevacizumab Injection \[15 mg/kg, intravenous infusion, D1, Q3W\]. Each treatment cycle is 21 days (Q3W). On-demand TACE therapy will be administered concurrently, with a maximum of 4 TACE sessions permitted. The interval between consecutive TACE sessions must be at least 4 weeks. Bevacizumab Injection must be withheld for at least 2 days prior to any TACE procedure. Study drug administration must resume at least 2 weeks after any TACE procedure. Subjects must have fully recovered from TACE prior to receiving study drugs. Investigators may delay dosing based on toxicity recovery, but study drugs should be administered as soon as feasible once requirements are met.
Treatment will continue until the investigator assesses no further clinical benefit for the subject, the subject experiences intolerable toxicity, withdraws consent, or meets other protocol-specified criteria for treatment discontinuation (whichever occurs first).
Safety Visits: After enrollment, safety assessments will be performed 2 weeks (14 ± 3 days) after each TACE procedure and on D1 of each study drug cycle prior to drug administration. Subjects will continue safety assessments and survival follow-up after treatment completion.
Safety Reporting Period: Starts from the first TACE treatment and ends 90 days after the last dose of Iparomlimab and Tuvonralimab Injection \[non-serious adverse events (AEs) unrelated to study drugs are collected only until 30 days after the last dose\], or 30 days after the last dose of Bevacizumab Injection, or 30 days after the last TACE procedure, whichever is later.
Survival Follow-up: After the safety visit period, survival status and subsequent anti-tumor therapies will be collected every 12 weeks (±7 days) via clinical or telephone follow-up until subject death, loss to follow-up, sponsor study termination, or other study completion criteria are met (whichever occurs first).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: